Prescription drug · ANDA
Furosemide NDC 0615-8368
Furosemide 20 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8368-05 | 00615836805 | 15 TABLET in 1 BLISTER PACK (0615-8368-05)Marketed from Dec 8, 2020 | |
| 0615-8368-07 | 00615836807 | 7 TABLET in 1 BLISTER PACK (0615-8368-07)Marketed from Jun 21, 2022 | |
| 0615-8368-10 | 00615836810 | 10 TABLET in 1 BLISTER PACK (0615-8368-10)Marketed from Nov 18, 2022 | |
| 0615-8368-14 | 00615836814 | 14 TABLET in 1 BLISTER PACK (0615-8368-14)Marketed from Jun 21, 2022 | |
| 0615-8368-28 | 00615836828 | 28 TABLET in 1 BLISTER PACK (0615-8368-28)Marketed from Apr 15, 2024 | |
| 0615-8368-30 | 00615836830 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8368-30) / 5 TABLET in 1 BLISTER PACKMarketed from Dec 14, 2020 | |
| 0615-8368-39 | 00615836839 | 30 TABLET in 1 BLISTER PACK (0615-8368-39)Marketed from Dec 8, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Furosemide
- Generic name (nonproprietary)
- furosemide
- Active ingredients
- Furosemide — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076796
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 0615-8368_fb99ad62-fc5e-4eab-9f63-20246541729cSPL ID fb99ad62-fc5e-4eab-9f63-20246541729cSPL set ID 114f4f4f-536a-4658-8fd0-2dd8c029b19aRxCUI 197732, 310429, 313988UNII 7LXU5N7ZO5
- Pharmacologic class
- Loop Diuretic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400615836805followed by a unit qualifier and the quantityPackage 00615-8368-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076796
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Furosemide | Furosemide 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1120 |
| Furosemide | Furosemide 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1119 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4445 |
| Furosemide | Furosemide 80 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1362 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1360 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1361 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-849 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3061 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4522 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4534 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-049 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-096 |
| Furosemide | Furosemide 80 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-033 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-030 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-032 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8369 |
| Furosemide | Furosemide 80 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8370 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1214 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1215 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | AvKARE | 42291-468 |
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